Abstract

Background

Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed
pregnancies. Studies from the USA suggest that brief intervention has promise for
alcohol risk reduction in antenatal care. However, further research is needed to establish
whether this evidence from the USA is applicable to the UK. This pilot study aims
to investigate whether pregnant women can be recruited and retained in a randomized
controlled trial of brief intervention aimed at reducing risky drinking in women receiving
antenatal care.

Methods

The trial will rehearse the parallel-group, non-blinded design and procedures of a
subsequent definitive trial. Over 8 months, women aged 18 years and over (target number
2,742) attending their booking appointment with a community midwife (n = 31) in north-east
England will be screened for alcohol consumption using the consumption questions of
the Alcohol Use Disorders Identification Test (AUDIT-C). Those screening positive,
without a history of substance use or alcohol dependence, with no pregnancy complication,
and able to give informed consent, will be invited to participate in the trial (target
number 120). Midwives will be randomized in a 1:1 ratio to deliver either treatment
as usual (control) or structured brief advice and referral for a 20-minute motivational
interviewing session with an alcohol health worker (intervention). As well as demographic
and health information, baseline measures will include two 7-day time line follow-back
questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated
in telephone follow-ups in the third trimester and at 6 months post-partum, when a
questionnaire on use of National Health Service and social care resources will also
be completed. Information on pregnancy outcomes and stillbirths will be accessed from
central health service records before the follow-ups. Primary outcomes will be rates
of eligibility, recruitment, intervention delivery, and retention in the study population,
to inform power calculations for a definitive trial. The health-economics component
will establish how cost-effectiveness will be assessed, and examine which data on
health service resource use should be collected in a main trial. Participants’ views
on instruments and procedures will be sought to confirm their acceptability.

Discussion

The study will produce a full trial protocol with robust sample-size calculations
to extend evidence on effectiveness of screening and brief intervention.